Clinical Research Associate II

AbbVie; Maidenhead; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading biopharmaceutical company in Maidenhead is seeking a Clinical Research Associate. The role involves monitoring clinical trials for adherence to protocols and regulations, managing site personnel, and ensuring data quality and participant safety. Candidates should have a health-related tertiary qualification and extensive experience in Oncology. Strong organizational and communication skills are essential, along with a thorough understanding of ICH/GCP guidelines. This position offers a dynamic work environment with a commitment to innovation and ethical standards.

Qualifications

• Extensive clinically-related experience in Oncology preferred.
• Current in-depth knowledge of regulations governing clinical research.
• Demonstrated business ethics and integrity.

Responsibilities

• Monitor activities of clinical investigative sites.
• Conduct site qualification and monitoring visits for studies.
• Oversee site personnel to meet study objectives.
• Ensure safety and protection of study subjects.
• Train site personnel on protocol and regulatory requirements.

Skills

Strong planning and organizational skills

Analytical and conceptual capabilities

Interpersonal skills

Communication skills

Knowledge of ICH/GCP Guidelines

Education

Tertiary qualification in a health-related field

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

• Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.


• Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-3 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.


• Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. Proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.


• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.


• Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.


• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.


• Manages investigator payments as per executed contract obligations. Negotiates investigator/hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.


• Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.

Qualifications

• Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.


• Extensive clinically-related experience in Oncology preferred.


• Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.


• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.


• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.


• Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.


• Demonstrated business ethics and integrity.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html